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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00036491
Date of registration: 10/05/2002
Prospective Registration: No
Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Public title: Anti-CD20 in Systemic Lupus Erythematosus
Scientific title: An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus
Date of first enrolment: January 2001
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00036491
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Robert A. Eisenberg, MD
Address: 
Telephone:
Email:
Affiliation:  University of Pennsylvania
Key inclusion & exclusion criteria

Inclusion Criteria

People may be eligible for this study if they:

- Are 18 to 70 years of age

- Agree to use a reliable method of birth control during treatment and for 6 months
after treatment ends

- Have SLE (by the American College of Rheumatology criteria)

- Have had SLE for at least 6 months prior to screening

- Have active SLE disease at the screening visit

- Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart)

- Have failed standard therapy, including at least 1 immunosuppressive agent, or have
experienced side effects from an immunosuppressive agent that required discontinuation
of treatment

- Meet blood, liver, and kidney laboratory values set by the protocol

- Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment

- Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before
the first week's visit. Oral corticosteroids may be altered as medically necessary
after enrollment.

- Have at least 1 elevated autoantibody level at screening visit.

Exclusion Criteria

People will not be eligible for this study if they:

- Are pregnant or breast-feeding

- Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other
diseases that may place the patient at risk if participating in the trial

- Have cranial neuropathy (a condition affecting the head region)

- Are on blood-thinning agents to prevent blood clotting

- Have a serious skin disease

- Have a certain class of heart disease

- Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia

- Have a long term serious infectious disease such as tuberculosis or a fungal infection
that is now active, or active within 2 years of the baseline visit

- Have had HIV infection or another immunosuppressive state (chemotherapy or radiation
therapy)

- Have received any experimental drug within 30 days of baseline visit

- Have received any monoclonal antibody or similar medication within 3 months of the
baseline visit

- Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks
of the baseline visit

- Abuse alcohol or drugs

- Are unwilling or unable to follow the protocol

- Have poor veins for receiving injections.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Lupus Erythematosus, Systemic
Intervention(s)
Drug: Rituximab
Primary Outcome(s)
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55]
Serum Autoantibodies [Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56]
Secondary Outcome(s)
Patient Global Assessment (VAS)
Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index for SLE
Renal Function [Time Frame: Measured by creatinine clearance and total protein.]
Short Form-36 Health Survey (SF-36)
Adverse Events
Modified Health Assessment Questionnaire (HAQ)
Erythrocyte Sedimentation Rate (ESR)
Prednisone Dose [Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56]
Systemic Lupus Activity Measure (SLAM) [Time Frame: Baseline, Week 4, Week 7, Week 11, Week 15, Week 19, Week 27, Week 39 and Week 55]
C3 and C4 complement levels
Physician Global Assessment (VAS)
Secondary ID(s)
ACE Study #AC002
UPenn #U1131s
DAIT AC002
SACCC #ASL02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Autoimmunity Centers of Excellence
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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